The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer

Biliary Tract Cancer (BTC) Clinical Trial

Official title:

The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05036486
• Other study ID #: T3221
• Status: Recruiting
• Start date: October 25, 2021
• Est. completion date: December 2030

Study information

• Verified date: August 2023
• Source: National Health Research Institutes, Taiwan
• Contact: Ming-Huang Chen, MD, PhD
• Phone: 886-2-28757270
• Email: mhchen9[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Recent progress in comprehensive genomic profiling for advanced BTC has helped to clarify tumorigenesis and facilitate the coming era of precision medicine. To further elucidate the underlying molecular genomic aberrations, as well as the clinical demographics and therapeutic outcomes, it is necessary to have a national, multi-centers and population-focused research project to collect data completely. Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis in a platform of data storage and sharing. The purpose of the precision medicine project is to establish tumor molecular profiling of BTC populations in Taiwan, to facilitate patients to have corresponding potential targeted therapeutics and suitable clinical trials.

Description:

Biliary tract cancer (BTC) compromises a heterogenous group of tumors with poor prognoses. Curative surgery remains the first choice for localized disease; however, most BTC patients had unresectable or metastatic disease. The gold standard therapy for these patients is chemotherapy with gemcitabine and cisplatin. There are no consensus guidelines for standard treatment in a second-line setting, although the data of the ABC-06 trial showed a slight survival benefit from oxaliplatin and 5-fluorouracil combination chemotherapy.

Recent progress in comprehensive genomic profiling for advanced BTC has helped to clarify tumorigenesis and facilitate the coming era of precision medicine. To further elucidate the underlying molecular genomic aberrations, as well as the clinical demographics and therapeutic outcomes, it is necessary to have a national, multi-centers and population-focused research project to collect data completely. Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis in a platform of data storage and sharing. The purpose of the precision medicine project is to establish tumor molecular profiling of BTC populations in Taiwan, to facilitate patients to have corresponding potential targeted therapeutics and suitable clinical trials.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Ages 20 and above.

2. Pathological reported showed adenocarcinoma or adenosquamous carcinoma for patients with BTC (include IHCC, EHCC, GBC or AVC) or hepatocholangiocarcinoma as locally advanced or metastatic status.

3. Willingness to provide the residual biopsy/operative slides.

4. Life expectancy more than 3 months.

5. Patients fully understand the protocol with the willingness to have regular follow-up.

6. Patients are ready to have 1st systemic treatment or under 1st line therapy

7. Total bilirubin ?5 mg/dL, and ECOG?2

Exclusion Criteria:

1. Inability to cooperate by providing a complete medical history.

2. No available tumor tissues for genetic testing.

3. Undesirable compliance.

4. Other malignancy within the past 1 years except adequately treated basal or squamous cell skin cancer or cervical cancer in situ.

Related Conditions & MeSH terms

• Biliary Tract Cancer (BTC)
• Biliary Tract Neoplasms

Intervention

Genetic:
• next-generation sequencing
Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital, Chiayi	Chiayi City
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital,	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei
Taiwan	MacKay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Medical University-Shuang Ho Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Linko Chang Gung Memorial Hospital	Taoyuan
Taiwan	Taoyuan General Hospital, Ministry of Health and Welfare	Taoyuan

Sponsors (14)

Lead Sponsor

Collaborator

National Health Research Institutes, Taiwan

Chang Gung Medical Foundation (Linkou Branch), Chang Gung Memorial Hospital, Chang Gung Memorial Hospital, Chiayi, China Medical University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Koo Foundation Sun Yat-Sen Cancer Center, Mackay Memorial Hospital, National Cheng-Kung University Hospital, National Taiwan University Hospital, Taipei Medical University Shuang Ho Hospital, Taipei Veterans General Hospital, Taiwan, Taoyuan General Hospital, Ministry of Health and Welfare, Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To enroll 400 patients who fit the criteria of this study in the enrolled period	To enroll 400 patients who fit the criteria of this study in the enrolled period	5 years
Primary	To perform large-scale NGS analysis for specific populations	To create a map containing important genetic characteristics	5 years
Secondary	Collect clinical data of Biliary tract cancer patients	Collect clinical data of Biliary tract cancer patients	5 years
Secondary	To correlate the clinical characteristics, treatment and outcome of Biliary tract cancer with the genetic profile in Taiwan.	To correlate the clinical characteristics, treatment and outcome of Biliary tract cancer patients	5 years